Home NDC 85248-044 Natucure HEMORRHOID
Product NDC 85248-044
11-digit product format 852480044
Labeler code 85248
Product ID 85248-044_544126ea-0b14-c342-e063-6394a90af29b
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine 4% Phenylephrine HCL 0.25% HEMORRHOID
Dosage form CREAM
Route TOPICAL
Labeler Jiangxi Yudexi Pharmaceutical Co., LTD
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-03
Substance PHENYLEPHRINE HYDROCHLORIDE; LIDOCAINE
Active strength .25; 4 g/100g; g/100g
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Natucure HEMORRHOID
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE .25 g/100g LIDOCAINE 4 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2529640 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85248-044-01 Natucure HEMORRHOID 42.5 g in 1 BOTTLE CREAM 42.5 3
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 8 of 156 · 3,115 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85248-044-01 85248004401 42.5 g in 1 BOTTLE (85248-044-01) 42.5 g 2026-02-03 No No Current